Quality Assurance Manager

2 weeks ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Daiichi Sankyo, Inc. This role will be responsible for ensuring the adherence to regulatory requirements and quality standards in our Quality Management System (QMS).

Key Responsibilities
  • Manage and maintain the QMS in accordance with regulatory requirements and industry standards.
  • Ensure the implementation of global and harmonized quality standards and regulatory requirements for GMP areas.
  • Develop and manage internal procedures to ensure adherence to quality standards and regulatory requirements.
  • Collaborate with cross-functional teams to ensure alignment with industry regulations and best practices.
  • Provide guidance and oversight of specific processes to ensure process excellence and compliance.
Requirements
  • Bachelor's Degree in a scientific discipline.
  • 4+ years of experience in pharmaceutical, biologicals, or vaccines, including first-hand knowledge of drug manufacturing, packaging, QA, compliance, and audit.
  • Proven experience working with various pharmaceutical dosage forms.
  • Demonstrated expertise in working directly with multinational drug regulators and external partners.
  • Solid understanding of quality management and continuous process improvement principles, including global cGMP requirements.
  • Previous management experience is strongly preferred.
Travel

Must have ability to travel up to 10% including overnight travel (international and domestic).

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.



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